The Office for Human Research Studies (OHRS), Graduate School of Medicine and Faculty of Medicine was established in October 2009 to raise the standard of research ethics offering research ethics support services to researchers.
Message from the Director
As a vice dean in charge of research ethics, I have been the director of the OHRS from an early stage of its establishment. At this office, we are working to ensure all human related researches at the Graduate School of Medicine and Faculty of Medicine of the University of Tokyo and at the University of Tokyo Hospital to be conducted in compliance with the principle of ethics of the Declaration of Helsinki and governmental regulations and guidelines. As the social context surrounding medical and health ethics is changing with increasing complexity, we have incorporated instructions, advices and opinions of people from various fields and enhanced both quality and quantity of our services.
Protecting research participants is our primary objective. And we believe that the Research Ethics Committee’s review that ensures studies to be scientifically rational and ethically appropriate can guarantee research quality, which results in protecting research participants/subjects. As the Office for Research Ethics Support, we support the committee. We also offer research ethics support services, foster research ethics specialists, and hold various seminars. We trust that high-quality research ethics support services can help maintain and improve the level of research ethics among researchers. The OHRS members and I will continue to work hard and improve the OHRS as a leader in the field domestically as well as internationally with a sincere hope that our ongoing efforts will make further contribution to the society.
Director, The Office for Human Research Studies
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Message from the Deputy Director
The advancement of medical science is quite remarkable. New treatment methods are developed one after the other and are contributing to the healing of patients.
However, for medical science to develop and be eventually applied to treat patients, basic medical research and clinical studies on human participants are indispensable.
During the World War II, human race experienced dire human experimentations. And even after the war, many atrocious medical researches on human subjects took place such as in Tuskegee Syphilis Study in the United States.
The study of research ethnics originated from reflection of such tragic events and emphasizes on protecting research participants. International guidelines were made for medical and health researches to be conducted in ethically appropriate manner and ethics committee system was established to review medical and health research protocols. In Japan, ethics committees began appearing in the 80s and have increased to 1,500 by now.
Nevertheless, medical research related misconducts have repeatedly been found. Clearly, guidelines and ethics committees alone do not resolve ethical problems. I came to think a mediating function might be needed for research ethics to properly take root in the mindset of researchers as well as people at large in the society.
Triggered by the research ethics scandal (samples were used without consent of the patients for research purpose) at the Institute of Medical Science of the University of Tokyo in 2008, I started to focus on establishing an OHRS in the Institute of Medical Science and an Office for Life Science Research Ethics and Safety at the headquarters. In 2009, the OHRS was established in the Faculty of Medicine of the University of Tokyo focusing on the ethical principles in conduct of medical and health research on human subjects. Both president office of the university and the Faculty of Medicine actively and publicly engaged in the preparation of the office aiming to gain the trust of patients and the society in our medical research and to have researchers realize the importance of research ethics.
At the OHRS, we mainly provide research ethics consultation to researchers as its main function. We also engage in fostering specialists on research ethics consultation and conducting various seminars. What I realized through the operation at the OHRS is that research ethics support is about to become a new academic discipline, which is indispensable in contemporary medical science and treatment. I sincerely hope that research ethics support as a function and as an academic discipline will contribute to a sound development of medical science and treatment and moreover to the benefit of patients.
Deputy Director, The Office for Human Research Studies
Chairman, the Ethics Committee
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Our primary objective is to protect health, rights and dignity of participants in human related researches. Without losing sight of this objective, we offer research ethics support services for researchers to be able to conduct an ethically sound research efficiently. In addition to our primary function as the Office for Human Research Studies, we plan and execute educational programs on research ethics, provide ethics education to researchers through support services, and foster research ethics specialists.
For more information
Our Work and Cooperation with Other Departments
Primarily, we function as the Office for Human Research Studies. We also function as the secretariat of the review committee for novel treatments, which examines clinical application of unapproved medication, medical devices, and treatment materials as they are on the borderline between research and treatment, and novel medical treatment technologies that can be considered as highly challenging. Furthermore, we plan and execute educational programs on research ethics, provide ethics education for researchers through support services, educate research ethics committee members, and foster research ethics specialists.
We also respond to queries and requests from the government including the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and Welfare and collaborating research institutions and function as a coordinator between other departments and research ethics committee members. Especially, coordination among the Department of Clinical Research Governance of the University Hospital, the Clinical Research Support Center, and the Administration Office is essential. To this end, we already have established a cooperative structure that makes our seamless operation possible. In April 2017, our function as the central ethics committee officially began. We believe that a close cooperation with related facilities allows execution of sound studies.
We offer research ethics support services to researchers.
Our research ethics consultation is extended to all medical and health studies except clinical trials and includes inquiries to find out if a research requires an ethical approval, support on how to prepare an application, screening of applications, and responding to any research ethics related queries.
Our credo is to be user friendly. We work with researchers in resolving problems they face from their standpoints. Our goal through our research ethics support services is that we will be able to educate researchers while learning together.
(for general consumers and patients)
Human researches take place in the development of products that are commonly found in your daily life such as gaming consoles and cosmetic products.
Also clinical studies with human participants are indispensable for new medical knowledge to be eventually applied to treat patients and for medical studies that are the foundation of the development of medical science.
Research ethics must be taken into consideration not only in the fields of medical science and treatments but also in manufacturing industry.
We hope that the information we provided here could make you interested in research/medical ethics.
We believe our role should be an interface between the society and medicine from research ethics point of view.
- Daisuke Yamazaki
- Machi Fukata
- Satomi Mukaide
- Sumio Tanabe
民間企業に勤務して四半世紀。 医療機器開発を担当し、倫理委員会を立ち上げて運営管理してきました。 産学連携を通じ、日本の医療が益々発展するよう微力ながら貢献したいと思います。